Z-1446-06

BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06...

Name: Z-1446-06 BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06...
Creator: Becton Dickinson & Company
Published: 2005-06-01
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2005-06-01 / Terminated

FDA source

Becton Dickinson & Company began a recall of BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06, Manufactured by BD in San Lorenzo, Puerto Rico on 2005-06-01. The reason FDA records is "Formulation problems-lower pH of the solutions may increase Red Blood Cell hemolysis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1446-06
Status: Terminated
Initiated: 2005-06-01
Posted: 2006-08-26
Terminated: 2006-08-25
Recalling firm: Becton Dickinson & Co
Product: BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06, Manufactured by BD in San Lorenzo, Puerto Rico.
Product code: GKE Osmotic Fragility Testing
Reason for recall: Formulation problems-lower pH of the solutions may increase Red Blood Cell hemolysis
FDA root cause: Other
Action: Recall letters were sent via first class mail on 7/11/2005 by US mail, return receipt requested. A second notification was sent 8/4/2005
Quantity in commerce: Lot # 5014328 - 1,980 kits; Lot 5159075 - 4,360 kits
Distribution: World wide-USA, Canada, Europe, Asia Pacific.
Product codes and lots: Catalog #365830 -- Lot numbers: 5014328 -- exp. June 2006; 5159075 -- exp. July 2006.

Product code GKE

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)