remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containi
Summary
The FDA issued a Class II for remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Strep by Remel, Inc. Reason: On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples.
Details
Source
Device Recall
External ID
Z-2531-2023
Action Date
2023-09-20
Status
Ongoing
Category
device
Product Description
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Lot/Code Info: UDI/DI 00848838010064, lot 668255, Exp. 04/26/2024
Quantity Affected: 139 units (13,900 tests)
Reason for Recall
On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples
Distribution
US Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-14
Company
Lenexa, KS
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 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Remel, Inc has 25 FDA actions in our database, including 25 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 (Remel, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Remel, Inc have FDA actions?
Remel, Inc has 25 FDA actions in our database, including 25 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2531-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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