Oak mix allergen tests recalled over barcode orientation misreading tube positions
Siemens Healthcare Diagnostics is recalling 34 units of IMMULITE 2000 Oak Mix Specific Allergen because barcode orientation causes the instrument to misread tube positions in the holder wedge.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: misread tube positions can associate a result with the wrong allergen, and no injuries are reported.
Plain-English summary
The IMMULITE 2000 Oak Mix Specific Allergen, Siemens material number 10386105, catalog number L2KUN6, is being recalled.
The barcode orientation on affected devices causes an incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 or IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognise the position of tubes within the wedge.
The recall covers 34 units, of which the record lists 1 in the United States and 33 outside it, carrying UDI-DI 00630414965970 from lot 627. Distribution was worldwide, including California and countries including Argentina, Australia and Austria. The FDA has classified the action as Class II.
Misrecognised tube positions can attach a result to the wrong allergen. Laboratories holding the affected lot should follow Siemens' instructions.
The recalled product
- Product
- IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 (4)
- Siemens Material Number (SMN): 10386105
- Model/Catalog: T77L2
- UDI-DI: 00630414965970
- Lot number: 627
Distribution
Part of a larger recall action
This product is one of 3 recalled by Siemens Healthcare Diagnostics, Inc. 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.
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