Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
Reported: April 10, 2019 Initiated: July 18, 2018 #Z-1076-2019
Product Description
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
Reason for Recall
The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
Details
- Recalling Firm
- Abbott Laboratories, Inc
- Units Affected
- 30 kits
- Distribution
- Distribution was made nationwide, including Puerto Rico. There was also government and military distribution. Foreign distribution was made to Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mexico, Moldova, Morocco, Netherlands, Netherlands (Curacao), New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, UAE, Uganda, United Kingdom, Uruguay, Vietnam, and Zimbabwe.
- Location
- Irving, TX
Frequently Asked Questions
What product was recalled? ▼
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.. Recalled by Abbott Laboratories, Inc. Units affected: 30 kits.
Why was this product recalled? ▼
The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2019. Severity: Moderate. Recall number: Z-1076-2019.
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