Reported Jun 8, 2016 · Terminated
The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
Abbott Laboratories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Laboratories · 100 Abbott Park Rd · Abbott Park, IL · 60064-3502
Is this the product you have?
- The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
- Lot codes and dates
- Product List Number 07K7220 with Lot #: 55900UI01with expiration date of 04/23/2016, 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 #: 60105UI00 with expiration date of 10/02/2016 and Lot #: 61106UI00 with expiration date of 11/27/2016. Product List Number 07K7225 - Lot #: 55900UI00 with expiration date of 04/23/2016, 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, Lot #: 61106UI01 with expiration date of 11/27/2016 and Lot #: 62263UI00 with expiration date of 11/27/2016.
- Amount recalled
- 39,346 units
Where it was sold
Why it was recalled
Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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