Z-0773-04

Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials

Name: Z-0773-04 Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials
Creator: Dade Behring , Inc.
Published: 2004-03-01
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-03-01 / Terminated

FDA source

Dade Behring , Inc. began a recall of Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials on 2004-03-01. The reason FDA records is "cloudy appearance or precipitate". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0773-04
Status: Terminated
Initiated: 2004-03-01
Posted: 2004-07-20
Terminated: 2004-08-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials
Product code: GFO Activated Partial Thromboplastin
Reason for recall: cloudy appearance or precipitate
FDA root cause: Other
Action: The recalling firm issued recall letters dated 3/4/04 to their direct accounts informing them of the problem and what to do if a vial is found to be cloudy.
Quantity in commerce: 77886 vials
Distribution: The products were shipped to one diagnostic facility in PA. The products were also shipped to Germany, Poland, Spain, France, Italy, Portugal, Mexico, Thailand, and Uruguay.
Product codes and lots: Lot numbers 523785, 523785A, 523785B, and 523787

Product code GFO

K955450Class IIPathromtin SlBehring Diagnostics, Inc. / cleared 1996-04-19

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)