Z-0818-2010

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

Name: Z-0818-2010 Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500 tests)...
Creator: Remel, Inc
Published: 2009-07-20
License: https://open.fda.gov/license/

Remel Inc / initiated 2009-07-20 / Terminated / root cause: manufacturing process

FDA source

Remel, Inc began a recall of Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500 tests). Oxoid Ltd., Wade Road, Basingstoke, Hants UK... on 2009-07-20. The reason FDA records is "The products may give false positive results with some non-Staphylococcus aureus strains". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0818-2010
Status: Terminated
Initiated: 2009-07-20
Posted: 2010-02-23
Terminated: 2012-04-25
Recalling firm: Remel Inc
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.
Product code: JWX Kit, Screening, Staphylococcus Aureus
Reason for recall: The products may give false positive results with some non-Staphylococcus aureus strains
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 50 boxes (47 DR0850M; 3 DR0850B)
Distribution: Nationwide Distribution -- MN, CT, FL, GA, CA, NY, MI, MO, PA, and IL.
Product codes and 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

Product code JWX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)