Z-1247-06

Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance...

Name: Z-1247-06 Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance...
Creator: Instrumentation Laboratory Co.
Published: 2006-03-07
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2006-03-07 / Terminated

FDA source

Instrumentation Laboratory Co. began a recall of Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of... on 2006-03-07. The reason FDA records is "Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1247-06
Status: Terminated
Initiated: 2006-03-07
Posted: 2006-07-18
Terminated: 2006-08-11
Recalling firm: Instrumentation Laboratory Co.
Product: Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of Hemoliance RecombiPlasTin Diluent. Hemoliance RecombiPlasTin after reconstitution with Hemoliance RecombiPlasTin Diluent is a liposomal preparation of recombinant human tissue factor and purified phospholipids, calcium chloride, buffer and a preservative. The use of recombinant human tissue factor and purified phospholipids assures uniformity in reagent purity, ISI values and performance from lot to lot. Once reconstituted, it is ready for use in the one-stage PT test. Hemoliance RecombiPlasTin Diluent is an aqueous solution of calcium chloride and a preservative. --- FOR IN VITRO DIAGNOSTIC USE.
Product code: GJS Test, Time, Prothrombin
Reason for recall: Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection).
FDA root cause: Other
Action: "Urgent Product Notifications" were sent to IL customers on 3/07/06 through its distributor, Beckman Coulter.
Quantity in commerce: 5 mL: 3870; 20 mL: 29,007 (all Domestic)
Distribution: Nationwide
Product codes and lots: Product No.49732750 (5 mL): Lots N0448239, N0549190, N0940581, N0353406, N0857200, N1050152; Product No. 49732720 (20 mL): Lots N0347895, N0548959, N0749495, N0940543, N0940586, N1242409, N0353410, N0454257, N0857199, N1050143.

Product code GJS

K925604Class IIOrtho(tm) Recombiplastin W/ortho DiluentOrtho Diagnostic Systems, Inc. / cleared 1993-03-12

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)