Recall Z-0818-2010
Remel, Inc · initiated July 20, 2009
Product
Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500 tests). Oxoid Ltd., Wade Road, Basingstoke, Hants UK. Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccarides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.
Codes / lots: 100-test boxes - Lot Numbers: J539110, Exp. Nov 2009, and J591710, Exp. Jan 2010; 500-test boxes - Lot Numbers: J577920, Exp. Jan 2010; and J610620, Exp. May 2010
Reason for recall
The products may give false positive results with some non-Staphylococcus aureus strains
FDA-determined cause: Process control
Action taken
Thermo Fischer Scientific, Remel Inc. issued letters dated July 20, 2009 via regular mail explaining the reason for recall, risks involved, and requested they discard all remaining product. A Product Inventory Checklist was enclosed to report the amount of product their customer discarded. A second letter dated October 19, 2009 was issued via certified mail. For further information, contact Thermo Fischer Scientific, Remel Inc. at 1-800-255-6730, Extension 3304185.
Details
- Recall number
- Z-0818-2010
- Initiated
- July 20, 2009
- Posted by FDA
- February 23, 2010
- Terminated
- April 25, 2012
- Product code
- JWX – Kit, Screening, Staphylococcus Aureus
- Quantity
- 50 boxes (47 DR0850M; 3 DR0850B)
- Distribution
- Nationwide Distribution -- MN, CT, FL, GA, CA, NY, MI, MO, PA, and IL.
- Recalling firm
- Remel, Inc, Lenexa, KS
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0817-2010 | Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Oxoid Ltd., Wade road…The products may give false positive results with some non-Staphylococcus aureus strains | 07/20/2009Terminated |