3PLUS1 Multilevel Plasma Calibrator Set recall
3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a…
Why was 3PLUS1 Multilevel Plasma Calibrator Set recalled?
Products do not meet stability criteria and may impact results.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Order No. 75128, Lots No. 2219 (expiration 05/01/2022) and 2320 (expiration 06/01/2023)
- Product
- 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a…
- Recalling firm
- Chromsystems Instruments & Chemicals GmbH
- Quantity
- 200 packaging units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA and NY; The countries of Australia, Belgium, Brazil, Germany, Finland, France, Greece, Israel, Italy, Canada, Croatia, Kuwait, Austria, Russia, Switzerland, South Africa, Taiwan, Turkey, and United Arab Emirates.
- Recall date
- December 16, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)