Z-1537-2014Class II

Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests)...

Name: Z-1537-2014 Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests)...
Creator: Bio-Rad Laboratories, Inc.
Published: 2014-04-08
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2014-04-08 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories, Inc. began a recall of Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The... on 2014-04-08. FDA classified it as Class II and gives the reason as "There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1537-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-08
Posted: 2014-05-02
Terminated: 2014-05-30
Recalling firm: Bio-Rad Laboratories Inc.
Product: Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.
Product code: JPD Hemoglobin A2 Quantitation
Reason for recall: There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: BIO-RAD Laboratories sent an URGENT: MEDICAL DEVICE LETTER in the US on April 8. 2014 and worldwide with letters sent to customers and subsidiaries on April 14, 2014. Subsidiaries were asked to translate the letter and distribute to all affected customers Custormer were asked to complete a CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM and fax it to the Bio-Rad CSD Regulatory Affairs Department at the number provided to confirm that you have received this important information
Quantity in commerce: 457 kits
Distribution: Worldwide Distrubution ; USA INCLUDING CA, NY, GA, NC, AL, NJ, CT, WA, NY, LA, Il, MA and Internationally to China, Australia, Canada, France, Great Britain, Hong Kong, Thailand, Singapore,and Brazil.
Product codes and lots: Catalog number: 270-2103 (250 tests; Reorder pack lot number: 64005302, Expiration: 4/2015; Catalog number: 270-2154 (500 tests) Reorder pack lot number: 64005207, Expiration: 6/2015; 64004750, Expiration: 11/2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1537-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1537-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-02

Product code JPD

K991127Class IIVariant II B-ThalassemiaBio-Rad / cleared 1999-06-10

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)