Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 26, 2018
Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
lack of 510K
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalled Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liq… - a moderate-severity action.
Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liq… was recalled by Clark Laboratories, Inc. (dba,Trinity Biotech USA) in December 26, 2018. Reason: lack of 510K. Check the official notice for the remedy. Verify recall #Z-0622-2019 with the FDA Devices before acting.
The recall
Clark Laboratories, Inc. (dba,Trinity Biotech USA) issued this moderate-severity FDA Devices recall-lack of 510K.
- Moderate
- severity level
- 252 units
- affected scope
- Class II
- classification
- December 26, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0622-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0622-2019) was formally reported on December 26, 2018, with the manufacturer initiating the action on November 1, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Clark Laboratories, Inc. (dba,Trinity Biotech USA) is listed as the recalling firm, operating out of Jamestown, NY. Federal records list the affected scope as 252 units.
The documented reason for this recall is: lack of 510K Distribution data in the federal record shows the product reached: IL, WV, NJ, AZ, MD, UT. 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 - 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 - 40,422 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
252 units
Related Recalls
6
0 from same agency
Product description
Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Reason for recall
lack of 510K
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0622-2019 |
| Date reported | December 26, 2018 |
| Date initiated | November 1, 2018 |
| Recalling firm | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Firm location | Jamestown, NY |
| Affected scope | 252 units |
| Distribution | IL, WV, NJ, AZ, MD, UT |
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-0622-2019) 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? ▼
Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.. Recalled by Clark Laboratories, Inc. (dba,Trinity Biotech USA). Units affected: 252 units.
Why was this product recalled? ▼
lack of 510K
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 26, 2018. Severity: Moderate. Recall number: Z-0622-2019.
Where was the recalled product distributed? ▼
Distribution: IL, WV, NJ, AZ, MD, UT.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0622-2019) 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 December 26, 2018. 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.