Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 27, 2015
Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.
Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst c…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Roche Diagnostics Operations, Inc. recalled Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, co… - a moderate-severity action.
Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, co… was recalled by Roche Diagnostics Operations, Inc. in May 27, 2015. Reason: Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certa…. Check the official notice for the remedy. Verify recall #Z-1622-2015 with the FDA Devices before acting.
The recall
Roche Diagnostics Operations, Inc. issued this moderate-severity FDA Devices recall-Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certa….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- May 27, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1622-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1622-2015) was formally reported on May 27, 2015, with the manufacturer initiating the action on March 23, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Roche Diagnostics Operations, Inc. is listed as the recalling firm, operating out of Indianapolis, IN. Federal records list the affected scope as 2558 units.
The documented reason for this recall is: Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst case, lead to inaccurately low Homocystei… Distribution data in the federal record shows the product reached: Nationwide Distribution-including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, , SC, TN, TX, VA, WA, and WV.. 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
2558 units
Related Recalls
6
3 from same agency
Product description
Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.
Reason for recall
Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst case, lead to inaccurately low Homocysteine results. An elevated level of Homocysteine is considered an important risk factor in the assessment of peripheral vascular disease. Falsely low values could lead to a delay of di
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1622-2015 |
| Date reported | May 27, 2015 |
| Date initiated | March 23, 2015 |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Firm location | Indianapolis, IN |
| Affected scope | 2558 units |
| Distribution | Nationwide Distribution-including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, , SC, TN, TX, VA, WA, and WV. |
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-1622-2015) 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? ▼
Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 2558 units.
Why was this product recalled? ▼
Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst case, lead to inaccurately low Homocysteine results. An elevated level of Homocysteine is considered an important risk factor in the assessment of peripheral vascular disease. Falsely low values could lead to a delay of di
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 27, 2015. Severity: Moderate. Recall number: Z-1622-2015.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution-including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, , SC, TN, TX, VA, WA, and WV..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1622-2015) 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 27, 2015. 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.