Z-1008-2009

Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the...

Name: Z-1008-2009 Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the...
Creator: Remel, Inc
Published: 2008-10-07
License: https://open.fda.gov/license/

Remel Inc / initiated 2008-10-07 / Terminated

FDA source

Remel, Inc began a recall of Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of... on 2008-10-07. The reason FDA records is "Control and test wells are reversed on some of the reaction cards". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1008-2009
Status: Terminated
Initiated: 2008-10-07
Posted: 2009-03-20
Terminated: 2009-07-30
Recalling firm: Remel Inc
Product: Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccharides 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: Control and test wells are reversed on some of the reaction cards.
FDA root cause: Pending
Action: The recalling firm issued Important Medical Device Customer Advisory Notice letters dated 10/7/08 via regular mail to their customers explaining the reason for recall. The letter requested that they review their inventory for the product lots indicated in the letter; discard all of the lot remaining in their inventory; complete and return the Product Inventory Checklist.
Quantity in commerce: 32 kits dist. by recalling firm
Distribution: Nationwide Distribution -- including MN, MI, IL, and NC.
Product codes and lots: Lot J054710, Exp. 2010.04.30

Product code JWX

K972030Class IStaphytect Plus/dryspot Staphytect PlusOxoid , Ltd. / cleared 1997-09-08

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)