Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 14, 2014
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.
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bio-Rad Laboratories, Inc. recalled Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154… - a moderate-severity action.
Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154… was recalled by Bio-Rad Laboratories, Inc. in May 14, 2014. Reason: There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and…. Check the official notice for the remedy. Verify recall #Z-1537-2014 with the FDA Devices before acting.
The recall
Bio-Rad Laboratories, Inc. issued this moderate-severity FDA Devices recall-There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and….
- Moderate
- severity level
- Class II
- classification
- May 14, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1537-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1537-2014) was formally reported on May 14, 2014, with the manufacturer initiating the action on April 8, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Bio-Rad Laboratories, Inc. is listed as the recalling firm, operating out of Hercules, CA. Federal records list the affected scope as 457 kits.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
457 kits
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1537-2014 |
| Date reported | May 14, 2014 |
| Date initiated | April 8, 2014 |
| Recalling firm | Bio-Rad Laboratories, Inc. |
| Firm location | Hercules, CA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1537-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bio-Rad Laboratories, Inc.. Units affected: 457 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 14, 2014. Severity: Moderate. Recall number: Z-1537-2014.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1537-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 14, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.