ARCHITECT HAVAB-G Calibrator recall
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
Why was ARCHITECT HAVAB-G Calibrator recalled?
Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light Units (RLUs) up to 94%. It has been confirmed that the increase in the calibrator RLU values may cause a decrease in the control values and patient results. Patient values generated using the impacted calibrator lot 08219BE00 may have changed interpretation from reactive to falsely non reactive. Results impacted may present as a (falsely) non reactive result that fall in the range between 0.50 to 0.99 S/CO.
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 08219BE00
- Product
- ARCHITECT HAVAB-G Calibrator, REF 6L27-01
- Recalling firm
- Abbott Gmbh & Co. KG
- Quantity
- 83 kits
- Distribution
- US in the states of: AZ, CA, CO, CT, FL, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OR, RI, SC, TN, TX, WA, WV
- Recall date
- December 4, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)