The Recall Desk
ModerateFDA (Devices)·Z-0799-2019·Announced 2019-02-13

Abbott Recalls ARCHITECT Total T3 Reagent Kits Due to Carryover

Abbott Ireland Diagnostics Division is recalling ARCHITECT Total T3 Reagent Kits because reagent carryover may cause depressed test results on specific platforms.

What this means for you

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is inaccurate test results (depressed values) due to reagent carryover, which is a significant diagnostic error but does not involve direct physical injury or death.

Plain-English summary

Abbott Ireland Diagnostics Division is recalling 191,410 units of the ARCHITECT Total T3 Reagent Kit. The product is a Chemiluminescent Microparticle Immunoassay (CMIA) used for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma. The kits are used on ARCHITECT i1000SR or i2000/i2000SR platforms.

The recall was initiated because samples tested using the ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to reagent carryover when testing on board with specific assays on the ARCHITECT i1000SR and i2000/i2999SR platforms. This issue affects the accuracy of the test results rather than posing a direct physical hazard to the patient.

The affected products were distributed worldwide, including nationwide distribution across the United States and to numerous international locations. The recall includes all lot codes for specific list numbers (Kit Configurations) 7K64 20, 7K64 25, 7K64 30, 7K64 35, 7K64 27, 7K64 32, and 7K64 37. Healthcare facilities and laboratories should stop using the affected reagent kits and contact Abbott for further instructions.

The recalled product

Product
ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
Manufacturer
Abbott Ireland Diagnostics Division
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
191,410

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 (6)

  • List number (Kit Configuration): 7K64 20 (4 x 100 test/kit)
  • 7K64 25 (1 x 100 tests/kit)
  • 7K64 30 (4 x 500 tests/kit)
  • 7K64 35 (1 x 500 tests/kit)
  • 7K64 27 (1 x 100 tests/kit)
  • 7K64 32 (4 x 500 tests/kit)

Distribution

Distributed nationwide across the United States.

The notice also names 45 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Abbott Ireland Diagnostics Division under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Abbott Ireland Diagnostics Division

See all →

Same hazard · inaccurate results

See all →