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Terminated

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

FDA Recall Z-0773-04 · Posted 2004-07-20

Recalling FirmDade Behring , Inc.
Recall StatusTerminated
Product CodeGFO
Date Initiated2004-03-01
Date Terminated2004-08-19
Product Quantity77886 vials

Reason for Recall

cloudy appearance or precipitate

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K955450PATHROMTIN SLBehring Diagnostics, Inc. · 1996-04-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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