Z-0616-03

Chlamydia OIA. For in vitro diagnostic use

Name: Z-0616-03 Chlamydia OIA. For in vitro diagnostic use
Creator: Thermo Biostar, Incorporated
Published: 2003-02-07
License: https://open.fda.gov/license/

Inverness Medical-Biostar, Inc. / initiated 2003-02-07 / Terminated

FDA source

Thermo Biostar, Incorporated began a recall of Chlamydia OIA. For in vitro diagnostic use on 2003-02-07. The reason FDA records is "Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0616-03
Status: Terminated
Initiated: 2003-02-07
Posted: 2003-03-06
Terminated: 2003-05-02
Recalling firm: Inverness Medical-Biostar, Inc.
Product: Chlamydia OIA. For in vitro diagnostic use.
Product code: LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Reason for recall: Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.
FDA root cause: Other
Action: All consignees were notified by telephone on 2/6/2003, followed by letter on 2/10/2003.
Quantity in commerce: 56 units
Distribution: Nationwide, and to France, New Zealand and Spain.
Product codes and lots: Catalog No. CHLINT, Lot No. 133354, 133174. Foreign distribution.

Product code LJC

K951010Class IChlamydia OiaBiostar, Inc. / cleared 1995-10-07

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)