Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 12, 2022
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-nega…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Qiagen Sciences LLC recalled QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223 - a moderate-severity action.
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223 was recalled by Qiagen Sciences LLC in January 12, 2022. Reason: The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes …. Check the official notice for the remedy. Verify recall #Z-0455-2022 with the FDA Devices before acting.
The recall
Qiagen Sciences LLC issued this moderate-severity FDA Devices recall-The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes ….
- Moderate
- severity level
- Class II
- classification
- January 12, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0455-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0455-2022) was formally reported on January 12, 2022, with the manufacturer initiating the action on November 8, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Qiagen Sciences LLC is listed as the recalling firm, operating out of Germantown, MD. Federal records list the affected scope as 376 kits.
The documented reason for this recall is: The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-nega… Distribution data in the federal record shows the product reached: Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution.. 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
376 kits
Related Recalls
6
3 from same agency
Product description
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Reason for recall
The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0455-2022 |
| Date reported | January 12, 2022 |
| Date initiated | November 8, 2021 |
| Recalling firm | Qiagen Sciences LLC |
| Firm location | Germantown, MD |
| Affected scope | 376 kits |
| Distribution | Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution. |
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-0455-2022) 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? ▼
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223. Recalled by Qiagen Sciences LLC. Units affected: 376 kits.
Why was this product recalled? ▼
The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 12, 2022. Severity: Moderate. Recall number: Z-0455-2022.
Where was the recalled product distributed? ▼
Distribution: Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0455-2022) 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 January 12, 2022. 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.