Beckman Coulter Access Total T4 Calibrator Recall, Class II

Class 2 Device Recall Access Total T4 Calibrator

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| | Class 2 Device Recall Access Total T4 Calibrator | |

1000 Lake Hazeltine Dr
Chaska MN 55318-1037 |
| For Additional Information Contact | Ian Pilcher
952-448-4848 |
| Manufacturer Reason
for Recall | Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications. |
| FDA Determined
Cause | Nonconforming Material/Component |
| Action | Pending |
| Quantity in Commerce | 2068 US, 2830 OUS |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Bangladesh, Bolivia (Plurinational State of), Bosnia and Herzegovina, Brazil, Canada, China, C¿te d'Ivoire, Croatia, Czechia, Denmark, Egypt, El Salvador, Ethiopia, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Republic of, Kosovo, Lebanon, Libya, Malawi, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Somalia, Spain, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, Uzbekistan, Viet Nam, Yemen. |
| Total Product Life Cycle | TPLC Device Report |

| 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. | |

| 510(K) Database | 510(K)s with Product Code = KLI |