QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567
Summary
The FDA issued a Class II for QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 1 by Microgenics Corporation. Reason: Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result valu.
Details
Source
Device Recall
External ID
Z-1284-2022
Action Date
2022-07-06
Status
Ongoing
Category
device
Product Description
QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3
Lot/Code Info: Model/Part Number: 10015573 UDI Codes: (01) 0884883 01259 2 (17) 220310 (10) 74175462 (01) 0884883 01259 2 (17) 220512 (10) 74267412 Lot Numbers: 74175462 74267412 Calibrators within the set: QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3
Quantity Affected: 615 kits
Reason for Recall
Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay.
Distribution
U.S.: AL, AZ, CA, DC, FL, IA, ID, IL, KY, LA, MA, NE, NJ, NM, OH, OK, PA, SC, TN, TX, and VA O.U.S.: Bangladesh, Brazil, Canada, Germany, India, Malaysia, Mexico, South Korea, and Thailand
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-20
Company
Fremont, CA
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 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Microgenics Corporation has 7 FDA actions in our database, including 2 recalls and 5 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 (Microgenics Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Microgenics Corporation have FDA actions?
Microgenics Corporation has 7 FDA actions in our database, including 2 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1284-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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