Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 13, 2013
Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.
Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room tem…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bayer Healthcare Llc recalled Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglob… - a moderate-severity action.
Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglob… was recalled by Bayer Healthcare Llc in November 13, 2013. Reason: Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined…. Check the official notice for the remedy. Verify recall #Z-0136-2014 with the FDA Devices before acting.
The recall
Bayer Healthcare Llc issued this moderate-severity FDA Devices recall-Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined….
- Moderate
- severity level
- Class II
- classification
- November 13, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0136-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0136-2014) was formally reported on November 13, 2013, with the manufacturer initiating the action on August 26, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Bayer Healthcare Llc is listed as the recalling firm, operating out of Sunnyvale, CA. Federal records list the affected scope as 138 Kits in US (Total 2452).
The documented reason for this recall is: Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months aft… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan.. 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
138 Kits in US (Total 2452)
Related Recalls
6
3 from same agency
Product description
Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.
Reason for recall
Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0136-2014 |
| Date reported | November 13, 2013 |
| Date initiated | August 26, 2013 |
| Recalling firm | Bayer Healthcare Llc |
| Firm location | Sunnyvale, CA |
| Affected scope | 138 Kits in US (Total 2452) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan. |
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-0136-2014) 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? ▼
Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.. Recalled by Bayer Healthcare Llc. Units affected: 138 Kits in US (Total 2452).
Why was this product recalled? ▼
Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2013. Severity: Moderate. Recall number: Z-0136-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0136-2014) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 November 13, 2013. 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.