Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Oxoid Ltd., Wade road, Basingstoke, Hants, UK. Latex sl
FDA device recall Z-0817-2010 · posted 2010-02-23 · Terminated
Recall details
- Recalling firm
- Remel, Inc
- Reason for recall
- The products may give false positive results with some non-Staphylococcus aureus strains
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWX
- Quantity affected
- 27 kits
- Distribution
- Nationwide Distribution -- MN, CT, FL, GA, CA, NY, MI, MO, PA, and IL.
- Date initiated
- 2009-07-20
- Date posted
- 2010-02-23
- Date terminated
- 2012-04-25
- Location
- Lenexa, KS
Monitor recalls programmatically
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