M-I-03-18: IDEXX Transition to the New SNAP. Beta-lactam Test Kit

HHS:PHS:FDA:CFSAN:OC:DCP:MSB
 
                                            5100 Paint Branch Parkway
                                            College Park, MD 20740-3835
 
                                                              M-I-03-18
 
                                                       December 19, 2003
 
 
TO:      All Regional Food and Drug Directors
      Attn:  Regional Milk Specialists
 
FROM:  	Milk Safety Branch (HFS-626)
 
SUBJECT:  	IDEXX Transition to the New SNAP. Beta-lactam Test Kit
 
 
Below is the text of a letter received by FDA from Larry Chaney, Ph.D., Dairy
Business Manager, IDEXX Laboratories, Inc.
 
"Based on FDA's approval of the transition to New SNAP. Beta-lactam test kits,
IDEXX Laboratories, Inc. will manage the inventory of the remaining SNAP
Beta-lactam product based on the customer's demand in an expeditious manner.  As
you may be aware, the product is available in both 20 test and 100 test kit
quantities.  While we will attempt to completely deplete the inventory of
current product, it may be necessary to sell New SNAP. Beta-lactam based on
customer's test kit quantity demand, creating a limited amount of time that the
two products will be sold.
 
Once the inventory of SNAP Beta-lactam product has been depleted from our
inventory, SNAP Beta-lactam test kits will no longer be sold in the United
States.  Once the expiration date of the SNAP Beta-lactam test kit has been
reached, this product will no longer be an acceptable test for regulatory use.
 
The attached file has the lot numbers and the associated expiration dates for
SNAP Beta-lactam test kits.  The expiration date of 7 July 2004 will be the last
date that SNAP Beta-lactam test kit and the SNAP Image reader will be acceptable
for regulatory use."
 
 
Based on the information provided in this letter, the next update of M-a-85 will
contain a date of 7 July 2004 as the last date that the current SNAP
Beta-lactam, both the visual and instrumental reading, can be used for NCIMS
testing.  It will also be the last date that the SNAP Image Reader can be used
for regulatory testing as it is not approved for use with the New SNAP.
Beta-lactam product.
 
 
Below is the file as cited in the text of the letter:
 
 
SNAP Beta-lactam Test Kits
 
Lot #         "Expiration Date"
249AY         25-Nov-03
354AY         28-Nov-03
516BY         12-Dec-03
535BY         19-Dec-03
573BY         21-Dec-03
459BY         8-Jan-04
137DY         15-Jan-04
825CY         18-Jan-04
603CY         22-Jan-04
696CY         28-Jan-04
800CY         23-Feb-04
801CY         2-Mar-04
190DY         19-Mar-04
399EY         25-Mar-04
222DY         8-Apr-04
543EY         21-Apr-04
660FY         18-May-04
522HY         26-May-04
706FY         2-Jun-04
916GY         9-Jun-04
510HY         24-Jun-04
628HY         07-Jul-04
 
 
Copies of this memorandum are enclosed for distribution to Regional Milk
Specialists, State Milk Regulatory Agencies, State Milk Laboratory Evaluation
Officers and State Milk Sanitation Rating Officers in your region. This
memorandum should be widely distributed to representatives of the dairy industry
and other interested parties and also will be available on the FDA Web site at
http://www.cfsan.fda.gov at a later date.
 
If you would like an electronic version of this document prior to it being
available on the CFSAN Web Site, please e-mail your request to
Robert.Hennes@cfsan.fda.gov.
 
 
								/ss/
 
 
      CAPT Robert F. Hennes, RS, MPH, Chief
      Milk Safety Branch
1
 
 
 
 
M-I-03-18	1	December 19, 2003