Allergy IgE universal kits recalled over barcodes misordering tubes in wedges
Siemens Healthcare Diagnostics is recalling 2,802 units of the 3gAllergy Specific IgE Universal Kit because barcode orientation causes the instrument to misread tube positions.
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 3gAllergy Specific IgE Universal Kit, Siemens material number 10380875, catalog number L2KUN6, containing the 3gAllergy Specific IgE Adjustor Antibody (L2UNS1) and Control Antibody (L2UNS2), 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 2,802 units, outside the United States only, carrying UDI-DI 00630414962269 from lots including 169 and 170. 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 affected lots should follow Siemens' instructions.
The recalled product
- Product
- 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6;
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 2,802
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 (7)
- Siemens Material Number (SMN): 10380875
- Model/Catalog: L2KUN6
- UDI-DI: 00630414962269
- Lot number: 169
- 170
- 171
- 172
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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