Z-1625-2008

Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 2-ml...

Name: Z-1625-2008 Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 2-ml...
Creator: Remel Inc
Published: 2007-10-23
License: https://open.fda.gov/license/

Remel Inc / initiated 2007-10-23 / Terminated

FDA source

Remel Inc began a recall of Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 2-ml tube, Catalog Number: R8325106, 20/pack, Remel... on 2007-10-23. The reason FDA records is "Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1625-2008
Status: Terminated
Initiated: 2007-10-23
Posted: 2008-05-14
Terminated: 2008-07-16
Recalling firm: Remel Inc
Product: Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 2-ml tube, Catalog Number: R8325106, 20/pack, Remel, Lenexa, KS 66215
Product code: LIB Device, General Purpose, Microbiology, Diagnostic
Reason for recall: Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions.
FDA root cause: Other
Action: Consignees were notified by an Important Medical Device Customer Advisory Notice on 10/23/07. The letter instructs users to review inventory and discard any affected products. The letter also instructs users to return a product inventory checklist by 11/23/07. For additional information, contact 1-800-447-3641.
Quantity in commerce: 554/2-ml packs
Distribution: Worldwide Distribution including USA and countries of Taiwan, Japan, and U.K.
Product codes and lots: Lot 521354

Product code LIB

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)