CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Cat
Summary
The FDA issued a Class II for CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determin by Randox Laboratories. Reason: The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and w.
Details
Source
Device Recall
External ID
Z-1286-2023
Action Date
2023-04-05
Status
Ongoing
Category
device
Product Description
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
Lot/Code Info: GTIN: 05055273201765 Batch: 588434
Quantity Affected: 2 kits
Reason for Recall
The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range
Distribution
PA, OH, WV
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-01
Company
Kearneysville, WV
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 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Randox Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Randox Laboratories have FDA actions?
This is the only FDA action we have on record for Randox Laboratories in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1286-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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