Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAP
Summary
The FDA issued a Class II for Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Hu by The Binding Site Group, Ltd.. Reason: Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point .
Details
Source
Device Recall
External ID
Z-0274-2022
Action Date
2021-12-01
Status
Terminated
Category
device
Product Description
Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S
Lot/Code Info: Model Number: LK018.S UDI Code: 05051700006477 Lot Number: 472776 Model Number:LK018.10S UDI Code: 05051700012201 Lot Number: 472664
Quantity Affected: 2,254 kits
Reason for Recall
Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.
Distribution
U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-15
Company
Birmingham
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 132 device recalls issued in the same week, part of 403 device-related FDA actions this month.
The Binding Site Group, Ltd. has 5 FDA actions in our database, including 3 recalls and 2 clearances.
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 (The Binding Site Group, Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Binding Site Group, Ltd. have FDA actions?
The Binding Site Group, Ltd. has 5 FDA actions in our database, including 3 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0274-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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