ARCHITECT CA 19-9XR Reagent Kit recall
ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The…
Why was ARCHITECT CA 19-9XR Reagent Kit recalled?
The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls however do not detect the upward shift and will test within range.
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 08849M500 exp. 10/13/2012; lot 08851M500 exp. 10/13/2012; lot 08852M500 exp. 11/30/2012; lot 08853M500 exp. 11/30/2012; lot 10040M500 exp. 11/30/2012; and lot 10122M500 exp. 11/30/2012
- Product
- ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The…
- Recalling firm
- Abbott Laboratories
- Quantity
- 316 kits - USA, 8,356 kits ROW
- Distribution
- Worldwide Distribution - US (nationwide) the states of: Alabama, Arkansas, Arizona, California, Florida, Iowa, Indiana, Louisiana, Michigan, Minnesota, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, Virginia, Washington, including Puerto Rico, and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mexico, Montenegro, Morocco, Netherlands, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Togo, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Vietnam.
- Recall date
- July 4, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)