ImmunoCAP Specific IgG, Antigen tg, Thyroglobulin
Phadia AB · Model 14-4507-01 · UDI-DI 07333066003993
JNL
Prescription
1
510(k) clearances
15
Adverse events
4
Recalls
13
Facilities
Description
ImmunoCAP Specific IgG, Antigen tg, Thyroglobulin
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-05 | Beckman Coulter, Inc. | IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results. |
| 2019-04-30 | Beckman Coulter Inc. | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422 |
| 2011-01-26 | Beckman Coulter Inc. | The recall was initiated after Beckman Coulter confirmed customer reports of reagent pack to pack variability for the Access Thyroglobulin Antibody II (TgAb) reagent lot numbers id |
| 2010-06-29 | Beckman Coulter Inc. | The affected Access Thyroglobulin Antibody II reagent may produce inaccurate results due to a change in the thyroglobulin that was used in the kits. |
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