Abbott ARCHITECT Estradiol Kit Recalled for Fulvestrant Interference
Abbott Laboratories is recalling ARCHITECT Estradiol Kits because interaction with the drug Fulvestrant causes falsely elevated estradiol results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves inaccurate test results due to drug interaction without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Abbott Laboratories is recalling 39,346 units of the ARCHITECT Estradiol Kit, a medical device intended to measure estradiol in plasma. The recall is due to an interaction with the drug Fulvestrant, which leads to falsely elevated estradiol results in patients treated with this medication.
The affected products were distributed worldwide, including in the United States and numerous international countries. Specific lot numbers and expiration dates are listed in the agency's recall record, covering Product List Numbers 07K7220 and 07K7225.
Healthcare providers and laboratories should stop using the affected kits and contact Abbott Laboratories for further instructions. Patients currently treated with Fulvestrant should consult their healthcare provider regarding the accuracy of their estradiol test results.
The recalled product
- Product
- The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
- Manufacturer
- Abbott Laboratories
- Affected units
- 39,346
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #: 55908UI01 with expiration date of 04/29/2016
- Lot #: 55941UI00 with expiration date of 04/23/2016
- Lot #: 57929UI00 with expiration date of 07/16/2016
- Lot #: 57931UI01 with expiration date of 07/27/2016
- Lot #: 55908UI00 with expiration date of 04/29/2016
- Lot #: 57929UI01 with expiration date of 07/16/2016
- Lot #: 57931UI00 with expiration date of 08/27/2016
- Lot #: 60105UI01 with expiration date of 02/10/2016
Distribution
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