arkray SPOTCHEM II Glucose Reagent test strips recall
arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in…
Why was arkray SPOTCHEM II Glucose Reagent test strips recalled?
One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.
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?
Lot Number EA4M78
- Product
- arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in…
- Recalling firm
- Arkray Factory USA, Inc.
- Quantity
- 88 boxes (25 foil packaged test strips per box)
- Distribution
- Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.
- Recall date
- January 27, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)