Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Summary
The FDA issued a Class I for Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TES by American Contract Systems, Inc.. Reason: Affected products were assembled off-site by individuals who may not have been properly trained..
Details
Source
Device Recall
External ID
Z-1277-2022
Action Date
2022-07-13
Status
Ongoing
Category
device
Product Description
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Lot/Code Info: UDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221
Quantity Affected: 274,400 kits total
Reason for Recall
Affected products were assembled off-site by individuals who may not have been properly trained.
Distribution
US distribution in the state of Minnesota.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-02
Company
Kansas City, MO
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 120 device recalls issued in the same week, part of 403 device-related FDA actions this month.
American Contract Systems, Inc. has 188 FDA actions in our database, including 188 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (American Contract Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Contract Systems, Inc. have FDA actions?
American Contract Systems, Inc. has 188 FDA actions in our database, including 188 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1277-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29