Food allergen panels recalled over barcodes causing wrong tube scanning order
Siemens Healthcare Diagnostics is recalling 28 units of Food Panel 3 Specific Allergen because barcode orientation causes the instrument to misread tube positions in the holder wedge.
What this means for you
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 Food Panel 3 Specific Allergen, Siemens material number 10385891, catalog number FP3L4, 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 record lists 28 units, outside the United States only, carrying UDI-DI 00630414960418 from lot 629. 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
- Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 28
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): 10385891
- Model/Catalog: FP3L4
- UDI-DI: 00630414960418
- Lot number: 629
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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