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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

bioMérieux, Inc. Issues Urgent Product Correction for VITEK® 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam

 

Contacts:
Media Relations
bioMérieux
Allan Mohess
Tel: +1 919-620-2937
allan.mohess@biomerieux.com

Fleishman-Hillard
Kimberly Mays
Tel: +1 919-620-2937
kimberly.mays@fleishman.com

 

FOR IMMEDIATE RELEASE - October 27, 2010 - DURHAM, N.C. - bioMérieux, Inc. on September 16, 2010, initiated a worldwide voluntary product correction of VITEK® 2 Gram Negative Susceptibility Cards containing the antibiotic Piperacillin/Tazobactam (TZPv). These cards, manufactured after March 10, 2009, are used in clinical laboratories to perform antimicrobial susceptibility testing as part of the VITEK® System. Clinical laboratories were notified to perform an alternative method of testing prior to reporting results for:

  • Piperacillin/Tazobactam (TZPvv) and Escherichia coli results
  • Piperacillin/Tazobactam (TZPvv) and Klebsiella pneumoniae with resistant results  

bioMérieux also provided instructions to implement suppression rules to prevent inappropriate reporting of results. Customers can continue to use the VITEK® 2 cards following the guidelines above.  

An internal investigation by bioMérieux confirmed user reports that VITEK® 2 antimicrobial susceptibility testing may incorrectly report E. coli and K. pneumoniae susceptible isolates as resistant to Piperacillin/Tazobactam (TZPv). This same investigation also found that E. coli isolates resistant to Piperacillin/Tazobactam (TZPv) may be incorrectly identified as susceptible 

Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam when infected with a resistant E. coli isolate. There have been no reports to date of treatment failures associated with either falsely-resistant or falsely-susceptible E. coli results for Piperacillin/Tazobactam (TZPv), or for falsely-resistant K. pneumoniae results. 

Attached below is a list of VITEK® 2 cards that are affected by this product correction. Of these affected cards, all lot numbers currently in distribution, as well as future distribution are affected until further notice. In addition, all new VITEK® 2 cards created that contain TZPv are affected by this product correction. 

bioMérieux has notified the U.S. Food and Drug Administration (FDA) and is working closely with the agency regarding this urgent product correction. Laboratories with questions should contact bioMérieux, Inc. at 1-800-682-2666, option 3, 24 hours a day; physicians should contact their clinical diagnostics laboratory for additional information if necessary. Consumers with questions should contact their physician. 

Adverse reactions or quality problems experienced with the use of the cards should be reported to bioMérieux by contacting Customer Service at 1-800-682-2666, option 3. Customers may also report adverse reactions or quality problems through FDA’s MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm; by regular mail using the postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/medwatch/getforms.htm; or by fax at 1-800-FDA-0178. 

About bioMérieux 

A world leader in the field of in vitro diagnostics for over 45 years, bioMérieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Our products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products. Other information can be found at www.biomerieux.com  

VITEK® 2 TZPv Affected Cards 

 

Card Name

Ref. #

 

Card Name

Ref. #

 

Card Name

Ref. #

 

Card Name

Ref. #

AST-N080

22214

 

AST-N117

22290

 

AST-N152

22347

 

AST-GN22

22227

AST-N081

22215

 

AST-N118

22291

 

AST-N153

22348

 

AST-GN23

22228

AST-N082

22217

 

AST-N120

22293

 

AST-N155

22352

 

AST-GN24

22229

AST-N084

22224

 

AST-N121

22295

 

AST-N156

22353

 

AST-GN25

22230

AST-N085

22225

 

AST-N122

22299

 

AST-N157

22354

 

AST-GN26

22244

AST-N086

22234

 

AST-N123

22301

 

AST-N158

22355

 

AST-GN27

22245

AST-N087

22235

 

AST-N124

22303

 

AST-N159

22356

 

AST-GN28

22254

AST-N088

22236

 

AST-N127

22308

 

AST-N160

22357

 

AST-GN29

22266

AST-N089

22237

 

AST-N128

22309

 

AST-N161

410026

 

AST-GN30

22267

AST-N090

22240

 

AST-N129

22310

 

AST-N162

410023

 

AST-GN31

22268

AST-N091

22241

 

AST-N130

22311

 

AST-N163

410084

 

AST-GN32

22269

AST-N093

22243

 

AST-N131

22315

 

AST-N164

410101

 

AST-GN33

22270

AST-N093

22246

 

AST-N132

22316

 

AST-N165

410102

 

AST-GN34

22271

AST-N094

22247

 

AST-N133

22318

 

AST-N166

410136

 

AST-GN35

22286

AST-N095

22249

 

AST-N134

22319

 

AST-N167

410138

 

AST-GN36

22300

AST-N096

22250

 

AST-N135

22322

 

AST-N168

410139

 

AST-GN37

22312

AST-N097

22251

 

AST-N136

22323

 

AST-N170

410222

 

AST-GN39

22337

AST-N098

22253

 

AST-N137

22324

 

AST-N171

410249

 

AST-GN40

410756

AST-N100

22256

 

AST-N138

22326

 

AST-N172

410298

 

AST-GN41

410757

AST-N103

22259

 

AST-N139

22327

 

AST-N174

410404

 

AST-GN42

410758

AST-N104

22261

 

AST-N140

22328

 

AST-N175

410403

 

AST-GN43

410759

AST-N105

22262

 

AST-N141

22329

 

AST-N176

410402

 

AST-GN44

410805

AST-N106

22264

 

AST-N142

22332

 

AST-N177

410392

 

 

 

AST-N107

22265

 

AST-N143

22333

 

AST-N178

410393

 

 

 

AST-N108

22272

 

AST-N144

22334

 

AST-N179

410640

 

 

 

AST-N109

22273

 

AST-N145

22338

 

AST-N180

410771

 

 

 

AST-N110

22274

 

AST-N146

22341

 

AST-N181

410803

 

 

 

AST-N111

22275

 

AST-N147

22342

 

AST-N182

410804

 

 

 

AST-N112

22281

 

AST-N148

22343

 

 

 

 

 

 

AST-N114

22283

 

AST-N149

22344

 

 

 

 

 

 

AST-N115

22285

 

AST-N150

22345

 

 

 

 

 

 

AST-N116

22289

 

AST-N151

22346

 

 

 

 

 

 

 

###

 

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