QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Summary
The FDA issued a Class II for QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 69122 by Qiagen Sciences LLC. Reason: The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected .
Details
Source
Device Recall
External ID
Z-0455-2022
Action Date
2022-01-12
Status
Terminated
Category
device
Product Description
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Lot/Code Info: LOT 210209 UDI (01)14053228038846(17)211127(10)210209(24)691223 Serial Numbers: 412092551 412092559 412092552 412092560 412092553 412092561 412092554 412092563 412092555 412092564 412092556 412092565 412092557 412092566 412092558 412092567
Quantity Affected: 376 kits
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.
Distribution
Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-08
Company
Germantown, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Qiagen Sciences LLC has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Qiagen Sciences LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Qiagen Sciences LLC have FDA actions?
Qiagen Sciences LLC has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0455-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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