Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500 tests). Oxoid Ltd.,

FDA device recall Z-0818-2010 · 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

50 boxes (47 DR0850M; 3 DR0850B)

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