Z-2246-2023 Class II Ongoing
FDA device recall Z-2246-2023 was initiated by Qiagen GmbH on May 19, 2023 and is designated Class II. Reason for recall: Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated The recall status is ongoing. Affected quantity: 4155 kits.
Recall Details
- Product Type
- Devices
- Report Date
- August 2, 2023
- Initiation Date
- May 19, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4155 kits
Product Description
QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214
Reason for Recall
Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
Distribution Pattern
DC, AL, CA, FL, GA, ME, NC, NY, OR, TX Foreign: DE, AE, AT, BE, BG, CH, CL, CY, CZ, DE, DK, ES, FI, FR, GB, GR, GT, HK, HU, ID, IN, IT, JO, MC, MU, MY, NL, NA, PL, PT, RO, SE, SK, TH, TN, TW, UY, YT, ZA
Code Information
LOT Numbers: LOTs 172043034, 172043348, 172043349, 172043369, 172044712, 172048091, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669, 172046775, 172048381 Exp. Date: 2023-10-06 and 2023-10-17